IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma

NCT00349934 | Completed Phase 1

• 2 other identifiers: P005Umanis-CRO0425
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

Open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting in patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of weekly paclitaxel (80 mg/m² at D1, D8 and D15 of a 4-week cycle). Three IMP321 doses (0.25, 1.25 and 6.25 mg) will be tested and given at D2 and D16 of this 4-week cycle, for 6 courses.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer; IMP321; hLAG-3Ig; LAG-3; CD223; Chemotherapy; Paclitaxel; Combination therapy

Outcome Measures

Primary Outcomes (2)

• Evaluate clinical and laboratory safety and tolerability profiles

  6 months

• Determine pharmacodynamic parameters

  6 months

Secondary Outcomes (1)

• Objective response rate (OR) using RECIST criteria

  6 months

Study Arms (1)

A

EXPERIMENTAL

IMP321

Biological: IMP321

Interventions

IMP321 BIOLOGICAL

This study is an open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting with patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle). Three IMP321 dose levels (250 µg, 1,250 µg and 6,250 µg) will be evaluated in three cohorts of 8 patients. At any given dose level the patients will be administered one dose every two weeks for a total of 24 weeks (12 s.c. injections in total), separated by 13-day intervals free of IMP321 administration. The repeated single doses will be administered on D2 and D16 of the 4-week cycles, on the day which follows chemotherapy.

Also known as: LAG-3, hLAG-3Ig, CD223

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage IV breast adenocarcinoma, histologically proven by biopsy of the primary tumor and/or a metastasis.
• Female not pregnant (or with negative pregnancy test) or male.
• Fertile patients must use effective contraception during and for 3 months after drug administration.
• years or above.
• ECOG performance status 0-1.
• Expected survival longer than three months.
• Resolution of toxicity of prior therapy to grade \< 2 (except alopecia).
• With or without prior adjuvant or neoadjuvant chemotherapy (authorized).
• With or without hormone therapy in adjuvant and/or the advanced setting (authorized).
• Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
• Biphosphonate therapy must have started at least 4 weeks prior to first dosing of the study drug.
• Asthma or chronic obstructive pulmonary disease allowed provided daily systemic corticosteroid therapy is not required.
• Total white cell count ≥ 3.109/L.
• Platelet count ≥ 100.109/L.
• Hemoglobin \> 9 g/dL or \> 5.58 mmol/L.

You may not qualify if:

• Prior chemotherapy for metastatic breast adenocarcinoma.
• Disease-free interval \< 12 months from last dose of adjuvant chemotherapy.
• Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
• Inflammatory carcinoma.
• Systemic chemotherapy, hormone or endocrine therapy given as breast cancer therapy within 30 days prior to first dosing of the study drug.
• Any investigational drug within 30 days prior to first dosing of the study drug.
• Candidate for treatment with trastuzumab or administration of trastuzumab within 30 days prior to first dosing of the study drug.
• Known cerebral or leptomeningeal metastases.
• Pregnancy or breast feeding.
• Serious intercurrent infection within the 30 days prior to first dosing of the study drug.
• Motor or sensory peripheral neuropathy ≥ 2 according to the National Cancer Institute criteria.
• Congestive heart failure.
• Active acute or chronic infection.
• Active autoimmune disease requiring immunosuppressive therapy.
• Known HIV positivity.

Sponsors & Collaborators

• Immutep S.A.S.: lead
• Umanis: collaborator

Study Sites (3)

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

Hôpital Tenon

Paris, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Related Publications (1)

• Brignone C, Gutierrez M, Mefti F, Brain E, Jarcau R, Cvitkovic F, Bousetta N, Medioni J, Gligorov J, Grygar C, Marcu M, Triebel F. First-line chemoimmunotherapy in metastatic breast carcinoma: combination of paclitaxel and IMP321 (LAG-3Ig) enhances immune responses and antitumor activity. J Transl Med. 2010 Jul 23;8:71. doi: 10.1186/1479-5876-8-71.

  PMID: 20653948 DERIVED

Related Links

• Sponsor's website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

soluble LAG-3 protein, human

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maya Gutierrez, M.D

  Centre René Huguenin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 7, 2006
• First Posted: July 10, 2006
• Study Start: July 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: January 1, 2010
• Last Updated: January 7, 2010

Record last verified: 2010-01

Locations

FR (3)